A13. SSJ SAM.gov.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Chronic Viral Diseases branch (CVDB) Division of High Consequence Pathogens and Pathology (DHCPP) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Centers for Disease Control and Prevention Atlanta, GA 30329-4018

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition and Assistance Branch II 2920 Brandywine Road Atlanta, GA 30341

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Procurement of plasma complement components testing services and expertise from the National Jewish Health Laboratory.

b. Procurement Request (PR) Number (if available): NA

2. Proposed Vendor and Estimated Procurement Amount (if available): PR87782

a. Proposed Vendor: National Jewish Health Advanced Diagnostic Laboratories, 1400 Jackson St. Denver, CO 80206. Tel: 1-303-398-1669, Email:

trollingerd@njhealth.org

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number: Click here to enter text.

D. Justification:

1. The justification for this non-competitive action is:

In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

Urgency

Exclusive licensing agreements/Proprietary data

Brand name required

Industrial mobilization

Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

Urgency

Only One Source

Logical Follow Up

Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The CDC ME/CFS research program has identified significant associations between Chronic Fatigue Syndrome (ME/CFS) and genetic variants within the complement activation pathway, specifically missense variants in the alternative pathway. The Georgia ME/CFS surveillance study, currently undergoing manuscript preparation, explored the correlation between plasma concentrations of complement proteins/activation products in the alternative pathway and ME/CFS, revealing elevated levels of complement protein C3 and significant associations with genotypes and disease characteristics. To further elucidate the role of the complement pathway in ME/CFS pathogenesis, our research program seeks to validate and expand upon these findings using samples from the multisite clinical assessment of ME/CFS (MCAM) cohort, enabling comprehensive analysis of complement components within this ME/CFS population. This study will also combine the power of correlation analyses between genetics, proteomics, and functional assays to identify markers potentially associated with ME/CFS and biological pathways, which may confer greater specificity for diagnosis and offer targets for intervention.

For these investigations, precise measurement and analysis of complement components, including precursor proteins (C3, FB), breakdown products (Bb), and regulators (FH), are paramount to understanding ME/CFS pathophysiology. The NJH lab can implement and perform sample controls in the new assay to manage batch effects, which enhances our ability to make precise comparisons across cohorts. This is crucial because their in-house batch effect control protocol requires previous use of their services. Any new lab would be unable to perform a reliable same sample-based batch effect comparison since we did not use them previously. As a result, comparisons between the previously assayed cohort and the new cohort would be impossible. Replicating, validating, and expanding our previous findings is imperative for understanding ME/CFS pathophysiology, and utilizing NJH will allow us to perform correlations between genetics, proteomics, and functional assays within the same cohort. The complement component assays conducted at National Jewish Health will ensure consistency between the GA and MCAM cohorts. Additionally, they will validate correlative studies that we have on the GA cohort complement component levels with genetic associations, with MCAM sample data acting as external controls for analyzing complement component level dynamics affected by missense SNPs in these cohorts. In order to maintain continuity and rigor in our research, it is imperative to engage their services once more to meet the rigorous standards and requirements of the CDC CFS research program. Lack of continuity between the two cohorts by not using NJH again would jeopardize the validity of our comparisons, undermining the reliability of our findings and potentially leading to inconsistent or misleading conclusions regarding ME/CFS pathogenesis.

Testing all proteins in a single lab is crucial for better precision in comparing the results, conserving the amount of plasma required for all analyses, and avoiding the need for multiple shipments when the biospecimen is limited. Our program’s market research shows that the National Jewish Health is the only CLIA certified laboratory that can perform all the requested tests from a single, low-volume aliquot of 200 µl of sample. Other labs would require splitting samples, which increases the volume needed. This would necessitate utilizing a larger portion of our highly valuable and already limited biorepository sample volumes, which we aim to preserve for additional experiments or to distribute to other researchers for further investigation into ME/CFS. Thus, ensuring all tests are conducted at NJH from a single shipment is vital for the integrity and efficiency of our study on ME/CFS.

b. What other products/services were considered and why did they not meet the need?

Laboratory Corporation of America, Quest Diagnostics, and MORL Laboratory were evaluated, but none offered the comprehensive testing required for this study.

Specifically, Laboratory Corporation of America and Quest Diagnostics could not offer all the required testing services, while MORL Laboratory did not meet the desired quality standards and required significantly larger sample volumes to perform assays, thereby depleting our valuable biorepository samples more so than what National Jewish Health would require for experiments. Furthermore, as we did not utilize these labs in our previous research, we cannot ensure the comparability of testing methods and validations. In contrast, utilizing National Jewish Health labs will ensure standardized data acquisition methods; this consistency of data acquisition is crucial as we aim to replicate our experiment in a new cohort, avoiding the introduction of confounding variables.

3. Program Office efforts to seek potential offerors:

We conducted an internet search for alternative laboratories; however, our primary consideration was to maintain consistency in testing methods and data acquisition, as demonstrated by our previous successful collaboration with National Jewish Health labs, and cost-effective discounts further solidified our decision to choose this group for these services. This decision was driven by the need to uphold the integrity and reliability of our research findings, ensuring a seamless transition to a new cohort without compromising the validity of our results.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title:

Center/Institute/Office COR/Program Official Signature:

Certification Date: June 11, 2024

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.